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临床试验/NCT00082290
NCT00082290已完成2 期

Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2003年5月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
92
试验地点
1
主要终点
reduction in pain

研究概览

简要总结

RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.

详细描述

OBJECTIVES:

  • Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
  • Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
  • Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
  • Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

reduction in pain

时间窗: 24 hours after treatment

A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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